Skin Closure in Prosthetic Joint Surgery: Comparative Evaluation of the "Barbed Sutures and Skin Glue" Technique (Cica-Pro)

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGroupe Hospitalier Diaconesses Croix Saint-Simon

About this trial

The choice of skin closure (staples vs. monofilament sutures vs. barbed sutures/adhesive) is critical for wound healing quality in prosthetic surgery (hip and knee). The combination of barbed sutures (e.g., Stratafix) and skin glue (e.g., Dermabond) is promising (superior cosmetic outcome, no suture removal, antimicrobial barrier) but has been poorly evaluated prospectively and comparatively in orthopaedics, which justifies this study. The primary objective is to compare the wound healing success rate at two weeks postoperatively between the patient groups. The primary outcome measure is successful wound healing, defined as the absence of wound complications (wound dehiscence, seroma, hematoma, early postoperative infection) during the first two weeks

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Men and women aged over 18 years

Patient who has provided written informed consent in duplicate

Patient scheduled for a primary hip or knee prosthesis implantation

BMI < 30 kg/m²

Disqualifiers

Patient expresses opposition to participating in the study

Patients under 18 years of age

Patient scheduled for prosthesis revision surgery

History of osteoarticular or soft-tissue infection

Trial design

Design model

Parallel

Treatments tested in this trial

  • primary knee replacement

    Procedure/Surgery

    For patients who have undergone knee replacement surgery (K), the study compares the success of wound healing in surgical wounds closed with barbed sutures and adhesive (Group K1) to those closed with staples (Group K2).

  • Primary hip replacement.

    Procedure/Surgery

    For patients who have undergone hip replacement surgery (H), the study compares the success of wound healing in surgical wounds closed with barbed sutures and adhesive (Group H1) to those closed with monofilament sutures (Group H2).

Treatment groups

400 Participants
are divided into 4 treatment groups
Group A: Group K1: Knee prosthesis, closed with barbed sutures and skin glue.Experimental treatment 1 intervention
Group B: Group K2: Knee prosthesis, closed with staples.Active comparator 1 intervention
Group C: Group H1: Hip prosthesis, closed with barbed sutures and skin glue.Experimental treatment 1 intervention
Group D: Group H2: Hip prosthesis, closed with monofilament suture.Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Rate of Successful Wound Healing at 2 Weeks Postoperatively

Proportion of patients with successful wound healing, defined as the complete absence of wound complications (dehiscence, seroma, hematoma, or early postoperative surgical site infection) during the first 2 postoperative weeks

Time frame
2 weeks postoperatively

Secondary outcomes

1

Severity Stage of Wound Complications According to DISH Classification

Categorization and staging of surgical wound complications (Dehiscence, Infection, Seroma, Haematoma) based on the international Delphi consensus DISH classification scale.

Time frame
2 weeks postoperatively
2

Patient-Reported Scar Aesthetic Quality Score

Assessment of the scar's aesthetic quality completed by the patient using a numerical rating scale from 0 to 100, where 0 represents the worst possible aesthetic outcome and 100 represents the best possible aesthetic outcome. Higher scores indicate greater aesthetic satisfaction.

Time frame
3 months postoperatively
3

Change from Baseline in Patient Anxiety Evaluated by Visual Analog Scale (VAS)

Patient self-reported anxiety level measured on a 10-cm Visual Analog Scale (VAS) ranging from 0 to 10, where 0 represents "no anxiety" and 10 represents "extreme/worst possible anxiety". Higher scores indicate higher levels of anxiety.

Time frame
Change from baseline at Week 1 and Week 2 postoperatively
4

Number of Unplanned Postoperative Wound-Related Medical Consultations

Total count of unplanned wound-related medical consultations (at outpatient clinics or emergency departments) per patient, as recorded in the patient follow-up logbook.

Time frame
Through 3 months postoperatively

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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